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Continuous Spinal Anesthesia in Renal Transplantation

Continuous Spinal Anesthesia for Renal Transplant Recipients

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03436368
Enrollment
60
Registered
2018-02-19
Start date
2018-02-20
Completion date
2026-12-31
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Renal Failure Chronic, Transplant;Failure,Kidney

Keywords

Continuous spinal anesthesia, General anesthesia, Renal transplantation, Chronic renal failure

Brief summary

Renal transplantation is now recognized as a treatment of choice for patients with end-stage renal disease. An adequate anesthetic technique should achieve hemodynamic stability and enhance perfusion of the transplanted kidney. The aim of this study is to assess the use & effects of continuous spinal anesthesia for kidney transplantation recipients, compared with balanced general anesthesia.

Interventions

Continuous spinal anesthesia will be performed for patients of the CSA group at the L3-L4 intervertebral space using Spinocath (B. Braun, Melsungen, Germany). After the cerebrospinal fluid is aspirated, 7.5 mg hyperbaric Bupivacaine 0.5% (1.5 ml) together with 25 micrograms Fentanyl (0.5 ml) will be injected intra-thecally. Supplemental injections will be given in aliquots of 5 mg hyperbaric Bupivacaine 0.5% (1 ml) if the sensory block is lower or reseeds, during surgery, below T6 dermatome.

PROCEDUREGeneral anesthesia

Anesthesia will be induced with intra-venous administration of Fentanyl (2 micrograms/kg), Ptopofol (1-2 mg/kg) and Atracurium (0.5 mg/kg). Maintenance will be achieved with 0.8-1.5% Isoflurane in an O2 / air mixture, an Atracurium infusion at 0.5 mg/kg/hr and a Fentanyl infusion at 1 micrograms/kg/hr.

Sponsors

Nazmy Edward Seif
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Using computer & sealed envelope randomization, patients are assigned to receive either continuous spinal anesthesia \[CSA group: n =30\] or general anesthesia \[GA group: n=30\]

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* ASA class III or IV * End-stage renal disease * Renal transplantation candidate patients

Exclusion criteria

* Any condition contra-indicating regional anesthesia * Coagulopathy * Allergic to any of the drugs used during the procedure

Design outcomes

Primary

MeasureTime frameDescription
Mean ABP12 hoursChange in Mean Arterial Blood Pressure measured in mmHg.

Secondary

MeasureTime frameDescription
Visual Analogue Score for pain VAS12 hoursVisual Analogue Score for pain measures the degree of pain experienced by the patient during the procedure. VAS is graded from 0-10 \[where 0=no pain, 10= worst pain\].
Patient satisfaction score24 hoursPatient satisfaction Score defines the degree of patient satisfaction with the anesthetic experience and is assessed after recovery. It is graded as excellent E (best score), fair F or poor P (worst score).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026